The FDA cited Lupin’s Novel Laboratories facility in Somerset, New Jersey, for its handling of out-of-specification results and other violations observed in a Dec. 3-21, 2018 inspection.

The agency investigator found 45 OOS invalidations caused by analyst errors since 2016, calling that “a notable number.” In 2018, no corrective or preventive actions were initiated for eight of the 11 invalidated OOS investigations chalked up to mistakes made by analysts.

The FDA also noted five investigations, with initiation dates ranging from July 2017 to July 2018, that remained open at the time of inspection without any justification.

The firm initiated multiple deviation investigations over OOS results for its nitrofurantoin oral suspension product, an antibiotic for treating urinary tract infections. In nearly all the investigations, the firm wrongly attributed the cause to sample preparation errors caused by inadequate mixing. The actual cause of the mixing problem—redacted in the publicly available version of the Form 483—was identified in 2018, nearly three years after the company wrongly classified the causes of the deviations.